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INFORMACIÓN DE PRODUCTO

Vigencia: Enero 2005

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GE5

Gel bactericida




Indice GE5 ................................................................................................................................................................................ 1 GEL BACTERICIDA GE 5.......................................................................................................................................... 3

Características del producto ....................................................................................................................................... 3 Forma de uso.............................................................................................................................................................. 3 Información ecológica y de seguridad ....................................................................................................................... 4 Información regulatoria.............................................................................................................................................. 4 Evaluación de eficacia ............................................................................................................................................... 5 GE4 y GE5 – Gel bactericida con acción residual ..................................................................................................... 7

Acción bactericida del alcohol: .............................................................................................................................. 7 Acción bactericida del triclosán: ............................................................................................................................ 7 Silicona y emolientes ............................................................................................................................................. 8

Pasos para un apropiado lavado de manos en seco ...................................................................................................... 13 Referencias bibliográficas............................................................................................................................................ 14

LAVADO DE MANOS Y PREPARACIÓN PREQUIRÚRGICA DE LA PIEL.................................................... 14 Higiene de manos..................................................................................................................................................... 15 Elimination of methicillin-resistant Staphylococcus aureus from a neonatal intensive care unit after hand washing with triclosan............................................................................................................................................................ 17 Use of 0.3% triclosan (Bacti-Stat) to eradicate an outbreak of methicillin-resistant Staphylococcus aureus in a neonatal nursery. ...................................................................................................................................................... 17 Triclosan: applications and safety. ........................................................................................................................... 18 Handwashing in a neonatal intensive care nursery: product acceptability and effectiveness of chlorhexidine gluconate 4% and triclosan 1%. ............................................................................................................................... 19 Surgical Infections ................................................................................................................................................... 19 Literature-Based Evaluation of the Potential Risks Associated with Impregnation of Medical Devices and Implants with Triclosan .......................................................................................................................................................... 19 Hygiene of the Skin: When Is Clean Too Clean? .................................................................................................... 20

Does Skin Cleansing Reduce Risk for Infection? ................................................................................................ 21 Skin Barrier Properties and Effect of Hand Hygiene Practices............................................................................ 23 Microbiology of Hands of Health-Care Professionals ......................................................................................... 24 When Is Clean Too Clean? .................................................................................................................................. 25 Recommendations for the General Public............................................................................................................ 26 Conclusions.......................................................................................................................................................... 28




GEL BACTERICIDA GE 5

Características del producto GE 5 es un gel de una composición desarrollada para obtener un producto agradable en el uso, con un buen poder bactericida persistente gracias a la formación de una fina película sobre la piel que retiene al activo (triclosán 0,3%), evitando su evaporación como ocurre en geles alcohólicos comunes; su formulación contiene una esencia que persiste luego de la aplicación y secado del producto, dejando un aroma cítrico durante un tiempo; y posee una viscosidad adecuada para dosificar mediante un dispenser. Su exclusiva formulación combina el alcohol etílico en la concentración a la que presenta su máximo poder bactericida (60% v/v) con agentes emolientes naturales que evitan el resecamiento de la piel provocado por las soluciones alcohólicas; y agentes neutralizantes que fijan el pH del producto en las cercanías del valor 5,5 correspondiente a pieles sanas. La inclusión de una silicona químicamente modificada para hacerla soluble y compatible con el resto de los componentes brinda un efecto de lubricidad y permite la formación de la película remanente al evaporarse los componentes volátiles luego de la aplicación. La utilización de materias primas de alta calidad: grado cosmético o USP permiten la obtención de un producto visualmente atractivo y estable. Ha sido desarrollado especialmente para la desinfección rápida de manos y/o piel cuando no es posible o necesario el lavado. Conviene aclarar que es importante que se aplique sobre las manos limpias, puesto que en presencia de suciedad visible primeramente se deberá practicar un lavado con algún jabón adecuado para obtener un efecto desinfectante seguro y persistente. De los estudios realizados en la etapa de desarrollo, se estableció un período de validez de 2 años para el producto conservado a temperaturas menores a 35ºC. Las propiedades fisicoquímicas del producto son: gel límpido amarillo brillante, con aroma alcohólico acompañado de nota cítrica persistente, su densidad es menor a la del agua pura.

Forma de uso Para la correcta desinfección de manos se deberá proceder según el siguiente esquema.

a) Colocar en una de las palmas una dosis de aproximadamente 2 ml del gel.




b) Friccionar enérgicamente las manos, palma sobre palma, entre los dedos y en

toda la superficie de los dedos y por último en la parte externa de las manos. Esta operación debe llevar como mínimo 30 segundos.

c) Una vez secado el producto, no necesita enjuague, las manos quedan desinfectadas por el efecto del alcohol y este efecto persiste durante un tiempo por acción del triclosán.

Información ecológica y de seguridad La estabilidad de la formulación ha sido estudiada en cuanto al mantenimiento del aspecto y de las propiedades fisicoquímicas enunciadas en la página 3 y al mantenimiento de la concentración de los activos germicidas en muestras conservadas por tiempos prolongados. Estas determinaciones están debidamente documentadas, han sido presentadas en ANMAT para la habilitación del producto y están disponibles los resultados y conclusiones. Los componentes del GE 5 son biodegradables. Al respecto hay información provista por los proveedores1. Por el nivel de alcohol este producto es inflamable, pero debido a su baja volatilidad y al contenido de agua, su temperatura de inflamación es superior al del alcohol etílico. A temperaturas ambientes es seguro y sólo deberá evitarse el contacto con llamas abiertas, ejemplos : mecheros, hornallas, sopletes, etc. La toxicidad aguda de cada componente está estudiada y es en todos los casos baja en términos de LD50 2; de todas maneras debe evitarse su ingestión y en caso de ingestión accidental consultar a un médico en lo posible con la información de la etiqueta y manual de uso.

Información regulatoria El gel GE 5 ha sido inscripto por Adox S.A. como producto de higiene personal en el Instituto Nacional de Medicamentos de la ANMAT, Nº de trámite: 4633/04 de fecha 10/12/04.3

1 Información de Clariant Argentina S.A. 2 Hojas técnicas de proveedores varios 3 Nota: la presente información está basada en el conocimiento de ADOX S.A sobre sus productos al día de la fecha. La utilización de esta información no exime de responsabilidad a quien transporte, almacene, manipule y utilice los productos.




Evaluación de eficacia Buenos Aires, Jueves, 29 de Diciembre de 2005 Protocolo Nº 95494 Remite Adox S. A. Muestra Declarada Gel Bactericida GE 5 Identificación Lote: 521021 Solicita Poder germicida Fecha Ensayo 26/12/2005 MATERIALES Y MÉTODOS: . Organismos Test: Se usaron los siguientes microorganismos: S. Aureus (ATCC 6538) y E. Coli (ATCC 8739) . . MEDIO DE CULTIVO: Se usó para todos los casos caseína-soya-agar. PREPARACIÓN DEL INÓCULO: . Previo al ensayo, se repicaron todos los microorganismos, de cultivos stock recientes, en el medio correspondiente. Se incubaron las bacterias a 30-35 ºC por 18 a 24 hs. La preparación del inóculo de los cultivos bacterianos se realizó lavando las superficies desarrolladas con solución fisiológica estéril hasta obtener una concentración de alrededor de 1 millón de microorganismos por ml. según el test de Mc. Farland. Se determinó el número de colonias revivificables por ml. en cada suspensión. . PROCEDIMIENTO: . El producto a probar fue dividido en 2 fracciones en forma estéril y contaminado mediante el agregado de los 2 microorganismos de prueba a razón de a uno por fracción. Todas las fracciones fueron incubadas a 20-25 ºC y se tomaron muestras a los 5 minutos para determinar el número de gérmenes revivificables. Todas las diluciones fueron realizadas en agua peptonada con Tween 80 al 5%. En tablas se dan los resultados obtenidos. . VALIDACIÓN DEL RECUENTO DE COLONIAS: . Las suspensiones de los microorganismos test fueron diluídas con agua peptonada al 0.1% hasta 1000 ufc/ml. aproximadamente. Tres placas de petri fueron usadas por cada microorganismo y se agregó 0.1 ml. de las suspensiones anteriores a las placas correspondientes. Al primer set de placas se agregó 1 ml. del producto diluído 10 veces. Al segundo set se agregó 1 ml. del producto diluído 100 veces. Al tercer set, que sirve de control, no se agregó producto. En las placas se agregó el medio de cultivo apropiado y se incubó a 30-35 ºC por 3 días para las bacterias, y a 20-25 ºC por 5 días para hongos. Luego de la incubación se contó el número

La empresa no se responsabiliza por los resultados del uso de los productos en situaciones no contempladas en la presente.




de colonias en cada placa y teniendo en cuenta el factor de dilución, se calculó el número de ufc/g. de producto. En tablas se muestran los resultados obtenidos. RESULTADOS DEL CHALLENGER TEST ----------------------------------------------------------------------------------------------------------------- . ................................unidades formadoras de colonias por g ................................Inóculo.......................5 min. ----------------------------------------------------------------------------------------------------------------- . S. Aureus................2.3 x 10^6.....................<100 . E. Coli.....................3.2 x 10^6......................< 10 ------------------------------------------------------------------------------------------------------------------ PROTOCOLO 95494 . RESULTADOS DE LA VALIDACIÓN DEL RECUENTO DE COLONIAS ------------------------------------------------------------------------------------------------------------------ Microorganismos Control Dilución 1:10 Dilución 1:100 Dilución 1:1000 Valida ------------------------------------------------------------------------------------------------------------------- ..........................................................ufc/g................................................ S. Aureus.....................96................31.........................94...................93....................1/100 . E. Coli........................107..............105........................102.................103.....................1/10 ---------------------------------------------------------------------------------------------------------------- . Conclusión: La muestra estudiada en la condiciones detalladas redujo la concentración del S. Aureus en un orden de 4 log. y la concentración del E. coli en un orden de 5 log.

Dr. J. D. Sapoznikow

Bioquímico El muestreo fue realizado por el laboratorio remitente.




GE4 y GE5 – Gel bactericida con acción residual

Acción bactericida del alcohol: El alcohol actúa como desnaturalizante de proteínas, es decir destruyendo la estructura cuaternaria de las mismas. Cuando esto sucede la proteína pierde su acción. Cuando el alcohol etílico toma contacto con las bacterias y/o virus, se produce el ataque a las estructuras proteicas externas de los mismos (membranas y/o cápsides) y se genera la pérdida de permeabilidad de las mismas, generando la lisis del microorganismo. Ahora bien, para que se lleve a cabo la desnaturalización, la proteína debe estar hidratada. Este es el motivo por el cual se usa alcohol etílico en diluciones variables entre el 60 y 70% v/v. El porcentaje de agua que existe en estas diluciones asegura la correcta hidratación proteica para que el alcohol ejerza su acción. Por otro lado resulta imprescindible que exista un tiempo mínimo de contacto entre el microorganismo y el alcohol. En este caso la presencia de vehículos gelificantes aseguran que, al menos los microorganismos se vean expuestos por 45’’ a la acción del mismo. El alcohol al 70% puede matar al 90% de las bacterias de la piel si se mantiene húmeda durante dos minutos. La clásica friega de manos con alcohol, que se deja secar, mata como máximo el 75% de las bacterias Según la última revisión del Mortality and Morbility Weekly Report (oct. 25, 2002/ nº 51) demuestra su buena actividad en la limpieza de las manos en el personal hospitalario, sobre todo en mezclas con otros compuestos (amonio cuaternarios, fenol, etc.), aunque no tiene efecto residual.

Acción bactericida del triclosán: El nombre químico del TRICLOSAN es 2,4,4, trichloro -2- Hydroxidiphenyl ether Es un compuesto no iónico, en polvo, blanquecino, color hueso y sin olor. Ofrece excelente estabilidad química en fórmulas compatibles. Su modo de acción está relacionado a la penetración en la pared celular, rompiendo la membrana citoplasmática, RNA, lípidos y síntesis de proteínas, resultando en la inhibición o muerte de los microorganismos. Una reciente revisión de Rhonda Jones (36) – resume la efectividad y seguridad del TRICLOSAN en el cuidado de la salud. Los estudios in Vitro y de efectividad clínica demostraron buena actividad contra bacterias gram positivas, gram negativas y bacterias mutirresistentes, especialmente tiene una excelente actividad para el Staphilococcus aureus meticilino resisitente (SAMR). Varios reportes demostraron que las preparaciones con TRICLOSAN pueden ser útiles para controlar el SAMR y las




epidemias por éste germen, usándolo para el lavado de manos y el baño de los pacientes. Los estudios in Vitro demostraron amplio espectro de actividad contra virus. La actividad para hongos, y micobacterias es algo inferior. El TRICLOSAN tiene rapidez de acción, excelente persistencia –4 horas- (36-41) y actividad acumulativa contra microorganismos residentes y transitorios. Su eficacia es inhibida mínimamente en presencia de materia orgánica, y tiene gran afinidad con la piel, no produciendo irritación ni efectos tóxicos incluyendo unidades de neonatología. Ha sido testeado en concentraciones del 0.3% al 2%. La mayoría de los productos antisépticos tienen concentraciones del 1%. Tiene una importante acción residual. Indicaciones Para Su Uso: El TRICLOSAN está disponible en una amplio rango de productos, incluyendo jabones para la preparación prequirúrgica de la piel, lavado de manos antiséptico, soluciones en base alcohólica, preservando jabones comunes, y en una amplia variedad de cosméticos, dentífricos, enjuagues bucales, etc. Se lo utiliza además como desinfectante de superficies y lavado de manos en la industria de la alimentación. Está indicado para el baño de pacientes prequirúrgicos, baño de pacientes y lavado de manos en caso de epidemias por SAMR, lavado de manos antiséptico y en soluciones con base alcohólica o con iodóforos para la preparación prequirúrgica de la piel en cirugía. En concentraciones del 0.3% para el baño de rutina de los pacientes por su actividad desodorizante.

Silicona y emolientes

Recomendación de ADECI: Cuidado de la piel Para asegurar un buen lavado de manos, hay un pre-requisito para que la piel luzca intacta y suave, es importante: • Tener disponible una buena crema de manos y usarla frecuentemente. • Que las soluciones alcohólicas para asepsia de las manos tengan un buen

emoliente. • Las cremas no deben ser usadas con las manos sucias o contaminadas Recuerde: La piel lesionada es siempre un perfecto medio ambiente para el desarrollo bacteriano.




Teniendo en cuenta estas recomendaciones, en la formulación de GE4 GE5, se añadió silicona y demás agentes emolientes que mantienen y cuidan la piel del usuario. En el caso especial de la silicona, esta se adhiere íntimamente a la piel después del uso de cualquiera de los dos productos y mantiene la piel aislada del medio ambiente formando un guante biológico. Este guante biológico no sólo genera una capa protectora, sino que mantiene la acción residual del triclosán luego de la evaporación del alcohol, favoreciendo la humectación de la piel. BIBLIOGRAFÍA: 1. Nenstiel R. y col. Hand washing a Century of Evidence Ignored – Clinician Reviews 7 (1): 55-58 – 61-62 1997. C.P.G and Williams & Wilkins. 2. Block Seymour. Historical Review - In Seymour Block Disinfection, Sterilization, and Preservation: 3-19 Fifth Edition, lippincot Eilliams & Wilkins Philadelfia USA 2001 3. CDC Centers for Disease Control And Prevention. Boyce J, Didier Pittet, The HICPAC/SHEA/APIC/IDSA Hand and Hygiene Task Force; and Healthcare Infection Control Practices Advisory Committee. Guideline for Hand Washing in Healthcare setting . www.cdc.gov – Mayo 2002 – 4. ADECI Asociación Argentina de Enfermeros en Control de Infecciones. Maimone s. Y col. Norma para el Lavado de Manos. Visión vol 2 Nº 4 5-18 Febrero 1998. 5. APIC Association for Professionals in Infection Control Larson E. Guideline for Hand washing and Hand Antisepsis in Health care Settings. 1995. 6. HICPAC Health Care Infection Control Advisory Committee – Guidelines for Hand Washing in Heath care Setting. Mayo 2002. 7. AORN Association of Operation Room Nurses . Standards, Recommended Practices and Guidelines hand Scrub Surgical 197-203;1997 EEUU 8. EPIC National Evidence – Based Guidelines for Preventing Healthcare Associated Infections Care Weekly. The epic Project. Journal Hospital Infection 2001- 47 (sup) WWW.doh.gov.uk/hai Inglaterra. 9. Jarvis W. Hand Washing The Semmelweis lesson forgotten? The Lancet Vol 348. Nov. 12,1994 –1311-1312 10. Brown J y col. High rate of hand contamination and low rate of hand washing before contact in a Neonatal Intensive Care Unit. The Pediatrics Inf. Dis. Jpurnal. Vol. 15 Nº 10. 908-910 1996 11. Saulnier F. y col. Assessing Excess Nurse Work Load Generated by Multiresistant Nosocomial Bacterial in Intensive Care ICHE Vol 22 : Nº 5 May 2001 273-279 12. Lennox K, Jarvis W y col. Patient Density Nurse – to – Patient Ratio and Nosocomial Infections Risk in a Pediatric Cardiac Intensive Care Unit. Ped. Inf. Dis. Journal. 16:1045-8 1997 Williams & Wilkins 13. Stegenga Jacob. The Role of Nurse Understaffing in Nosocomial Viral Gastroinestinal Infections on a General Pediatrics Ward ICHE Vol 23 (3) March 2002 14. Pittet D. and col. Efectiveness of a Hospital-Wide programme to improve compliance with hand hygiene. The Lancet vol. 356:1307-12 octubre 14 may 2000 15. Peter Heseltine Why don´t doctors and nurses wash their hands? ICHE vol 22 4-199-201 Apr. 2001 16. Boyce J Antiseptic Technology: Access, Affordability and Acceptance Emerging Inf. Diseases Vol 7 Nº 2 March Apr. 2001




17. Voss A Widmer - No Time for Hand Washing? Hand washing Vs. Alcoholic rub: Can we Afford 100% Compliance? ICHE 18:205-208 1997 18. Larson Elaine. Hygine of the Skin: When is clean to clean? Emerg. Inf. Dis. Vol 7 N º 2 , 225-30 March-apr 2001 19. Dinah Gould y col. Hand Decontamination Nursing Standard. Infection Control vol 15 Nº 2000 45-54. 20. Larson E. Quantity of soap as a variable in hand washing. Infections Control 1987 sep;8(9):371-5 21. Rotter M. Hand Washing and Disinfection. In Mayhall G Hospital Epidemiology and Infection Control Philadelphia. Lippnicott Williams and Wilkins 1999:1339-1355 22. Hobson D. y col. Development and evaluation of a new alcohol based surgical hand scrub formulation with persistent antimicrobial characteristics and brushes application. American Journal Infection Control 1998;26:507-512 23. Shelly McNeil y col. Outbreak of Sternal Surgical Site Infections Due to Pseudomonas aeruginosa Traced to a Scrub Nurse with Onychomycosis Clinical Infectious Diseases 2001;33:317-23 317-323 24. McNeil SA y col. Effect of hand cleansing with antimicrobial soap or alcohol based gel on microbial colonization of artificial fingernails worn by health care workers. Clin Inf Dis 2001;32(3):367-372 25. Parry MF y col. Candida osteomyelitis and diskitis spinal surgery: an outbreak that implicates artificial nail use CID 2001;32(3):352-357 26. Didier Pittet Improving Adherence to hand hygiene practice: A multidisciplinary approach Emerging Infectious Diseases Vol 7, Nº2 march-april 2001 237-240 27. Larson E y col. Changes in bacterial flora associated with skin damage on hands of health care personnel 28. Kelly M Pyrek . Operation Room Topics. Pre-op prep should safeguard skin integrity . Infetion Control Today - may 2002 29. Tenorio R y col Effectiveness of gloves in preventing personnel hand carriage of vancomycin- resistant enterococcus (VRE) after patient care. Clin Infect Dis 2001;32: 826-829. 30. Olsen R. Lynch P. y col examination gloves as barrier to hand contamination in clinical practice. JAMA 1993;270:350-353 31. Doebbeling B y col Removal of nosocomial pathogens from the contaminated glove. Ann Intern Med 1988;109:394-398. 32. Patterson J y col Association of contaminated gloves with transmission of Acinetobacter cacoaceticus var. anitratus in an intensive care unit Am J Med 1991;91:479-483 33. CDC Guideline for Prevention of surgical site infection 1999 34. Robert Bays y col Selecting the right surface disinfectant Infection Control Today -jun 1999 Virgo Publishing Inc. 35. Paul Goddard and Karen McCue Phenolic Compound. In Block S. Disinfection, Sterilization, and Preservation Fifth edition Lipnicott Williams & Wilkins 2001 255-282 36. Rhonda Jones y col Triclosan: A review of effectiveness and safety in health care settings AJIC Am J Control 2000;28:184-96 37. Faoagali J y col Comparison of the antibacterial efficacy of 4% chlorhexidine gluconate and 1% Triclosan hand wash products in an acute clinical ward. AJIC 1999;27:320-6 38. Faogali J. y col. Comparison of the immediate, residual, and cumulative antibacterial effect of Novaderm R, Novascrub R, Betiadine Surgical Scrub, Hobiclens, and liquid soap AJIC vol 23, Nº 6 1995 337-343 39. Perencevich Eli y col. National and Regional assessment of the antibacterial soap




market: a step toward determining the impact of prevalent antibacterial soaps. AJIC 2001;29:281-3 40. Messager S y col Efficacy of antiseptics tested on skin ICHE may 2001;22:325-5 41. Kovach T Managing infection during hand washing with a newly patented activated Triclosan technology Infection Control Today - may 2002 42. Rhonda Jones Bacterial resistant and topical antimicrobial wash products AJIC 1999;27:351-63. 43. Archibald L y col Serratia marcescens outbreak associated with extrinsic contamination of 1% chloroxylenol soap ICHE 1997;18:704-709 44. McGuckin M y col Patient education increases staff hand washing ICHE sep 2001;22:596-9 45. Fendler E y col The impact of alcohol hand sanitizer use on infection rates in an extended care facility AJIC 2002;30:226-233-4 46. Gina Pugliese; Martin Favero Alcohol rubs: CDC’s new hand hygiene guidelines ICHE 2001;22: 56-1 47. Cardoso Celso y col. Effectiveness of hand cleansing agents for removing Acinetobacter baumanii strain from contaminated hands. AJIC 1999;27:327-31 48. Guihermetti M y col. Effectiveness of hand cleansing agents for removing meticillin resistant Staphilococcus aures for contaminated handsICHE 2001;22:105-108 49. Paulson Daryl y col. A close look at alcohol gel as an antimicrobial sanitizing agent AJIC 1999;27:332-8 50. Herruzo Cabrera R. Y col Clinical assay of N-duopropenide alcohol solution on hand application in multirresistant Klebsiella pneumoniae in a newborn intensive care unit with this measure AJIC 2001;29-3 51. Didier Pittet and John Boyce Hand hygiene and patient care: pursuing the Semmelweis legacy. The Lancet Infectious Diseases 2001: 9-19 52. Ali Y , Larson E. y col. Alcohols . In Block S. Disinfection, Sterilization, and Preservation Fifth edition Lipnicott Williams & Wilkins 2001 229-254. 53. Merianos J Surface Active Agents. . In Block S. Disinfection, Sterilization, and Preservation Fifth edition Lipnicott Williams & Wilkins 2001 283-320 54. Salemi Ch. Y col Hand washing and physicians: How to get them together. ICHE Jan 2002;23:32-36-1 55. Boyce J It is time for action: Improving hand hygiene in hospitals. Annals of Internal Medicine 1999;130:153-155-2 56. Gina Pugliese and Martin Favero. Skin tolerance and effectiveness of two hand decontamination procedures ICHE 2000;21:11-751 57. William E. Trick y col. Impact of ring wearing on hand contamination and comparison of hand hygiene agents in a hospital. Clinic. Infec. Diseas. 2003:36 (June) 58. Stephan harbarth, Didier Pittet y col. Interventional Study to evaluate the impact of an alcohol-based hand gel in improving hand hygiene compliance. Pediatr Infec Dis. 2002;21:489-95 by Lippincott Williams & Wilkins, Inc. 59. Parienti J y col.Hand – Rubbing with an Aqueous Alcoholic Solution Vs Traditional Surgical Hand-Scrubbing and 30-day Surgical Site Infection Rates. JAMA, august 14, 2002- vol 288, Nº 6.




Pasos para un apropiado lavado de manos en seco




Referencias bibliográficas Tomado de CODEINEP http://www.codeinep.org/CONTROL/cdeiactualizacioneslavadomanosypppiel1.htm

LAVADO DE MANOS Y PREPARACIÓN PREQUIRÚRGICA DE LA PIEL b. Derivados Sintéticos de los Fenoles Si bien hay decenas de derivados sintéticos de los fenoles, los testeados en el campo de la salud, son el TRICLOSAN y el PCMX TRICLOSAN Características: El nombre químico del TRICLOSAN es 2,4,4, trichloro -2- Hydroxidiphenyl ether Es un compuesto no iónico, en polvo, blanquecino, color hueso y sin olor. El TRICLOSAN fue desarrollado en la década del 60 por la compañía CIBA GEIGY, con base en Suiza y se distribuye como IRGASAN DP 300. Ofrece excelente estabilidad química en fórmulas compatibles4. Su modo de acción está relacionado a la penetración en la pared celular, rompiendo la membrana citoplasmática, RNA, lípidos y síntesis de proteínas, resultando en la inhibición o muerte de los microorganismos. Eficacia: La efectividad del TRICLOSAN puede verse afectada por el pH y los surfactantes base, emolientes, humectantes, y naturaleza iónica de la formulación. La formulaciones deben ser testeadas en estudios in vitro, ya que su eficacia está relacionada a las fórmulas compatibles. Una reciente revisión de Rhonda Jones5 – sumariza la efectividad y seguridad del TRICLOSAN en el cuidado de la salud. Los estudios in vitro y de efectividad clínica6,7,8,9,10,11,12 demostraron buena actividad contra bacterias gram positivas, gram

4 35. Paul Goddard and Karen McCue Phenolic Compound. In Block S. Disinfection, Sterilization, and Preservation Fifth edition Lipnicott Williams & Wilkins 2001 255-282 5 Rhonda Jones y col Triclosan: A review of effectiveness and safety in health care settings AJIC Am J Control 2000;28:184-96 6 Rhonda Jones y col Triclosan: A review of effectiveness and safety in health care settings AJIC Am J Control 2000;28:184-96 7 Faoagali J y col Comparison of the antibacterial efficacy of 4% chlorhexidine gluconate and 1% Triclosan hand wash products in an acute clinical ward. AJIC 1999;27:320-6 8 Faogali J. y col. Comparison of the immediate, residual, and cumulative antibacterial effect of Novaderm R, Novascrub R, Betiadine Surgical Scrub, Hobiclens, and liquid soap AJIC vol 23, Nº 6 1995 337-343




negativas y bacterias mutirresistentes, especialmente tiene una excelente actividad para el Staphilococcus aureus meticilino resisitente (SAMR). Varios reportes demostraron que las preparaciones con TRICLOSAN pueden ser útiles para controlar el SAMR y las epidemias por éste germen, usándolo para el lavado de manos y el baño de los pacientes. Los estudios in vitro demostraron amplio espectro de actividad contra virus. La actividad para hongos,y micobacterias es algo inferior. El TRICLOSAN tiene rapidez de acción, excelente persistencia –4 horas- y actividad acumulativa contra microorganismos residentes y transitorios. Su eficacia es inhibida mínimamente en presencia de materia orgánica, y tiene gran afinidad con la piel, no produciendo irritación ni efectos tóxicos incluyendo unidades de neonatología. Ha sido testeado en concentraciones del 0.3% al 2%. La mayoría de los productos antisépticos tienen concentraciones del 1%. Debe estar formulado con detergentes aniónicos y pH ácido a neutro(36). El TRICLOSAN es compatible con la iodopovidona y el alcohol. Indicaciones Para Su Uso: El TRICLOSAN está disponible en una amplio rango de productos, incluyendo jabones para la preparación prequirúrgica de la piel, lavado de manos antiséptico, soluciones en base alcohólica, preservando jabones comunes, y en una amplia variedad de cosméticos, dentífricos, enjuagues bucales, etc. Se lo utiliza además como desinfectante de superficies y lavado de manos en la industria de la alimentación. Está indicado para el baño de pacientes prequirúrgicos, baño de pacientes y lavado de manos en caso de epidemias por SAMR, lavado de manos antiséptico y en soluciones con base alcohólica o con iodóforos para la preparación prequirúrgica de la piel en cirugía. En concentraciones del 0.3% para el baño de rutina de los pacientes por su actividad desodorizante. BRITISH MEDICAL JOURNAL BMJ 2001;323:411-412

Higiene de manos L. TEARE, B. COOKSON (Hand Hygene Liaison Group, Laboratorio Chelmsford Public Health, and Public Health Laboratory Service, Londres, Reino Unido)

La cuestión ya no es si la higiene de manos es efectiva o no, sino como lograr un incremento sostenido en la aceptación de los trabajadores de la salud. El frotado de las manos con alcohol luego del contacto con los pacientes reduce la transmisión de infecciones. En el año 1999 el Hand Washing Liaison Group (HWLG), un grupo de profesionales interesados en la disminución de la transmisión de infecciones, llamó la atención en el

9 Perencevich Eli y col. National and Regional assessment of the antibacterial soap market: a step toward determining the impact of prevalent antibacterial soaps. AJIC 2001;29:281-3 10 Messager S y col Efficacy of antiseptics tested on skin ICHE may 2001;22:325-5 11 Kovach T Managing infection during hand washing with a newly patented activated Triclosan technology Infection Control Today - may 2002 12 Rhonda Jones Bacterial resistant and topical antimicrobial wash products AJIC 1999;27:351-63




BMJ sobre la importancia del lavado de manos en la reducción de las infecciones adquiridas intra hospitalarias. El tema obtuvo otra vez prominencia con la publicación de las guías de lavado de manos por el departamento de Salud de Inglaterra. El desafío actual es asegurar la implementación de las guías en la práctica diaria. Reconociendo el hecho de que el lavado de manos no es el único ni más efectivo método para reducirla transmisión de gérmenes, el grupo ha cambiado de nombre por el de Hand Hygiene Liaison Group. Las infecciones intrahospitalarias en Inglaterra cuestan alrededor de 1 billón de libras por año y afectan al 10% de los pacientes, causando más de 5.000muertes por año (más que las muertes en las rutas) y ocupando 200 camas por día en los hospitales. El Staphylococcus aureus meticilino resistente (SAMR), un marcador de infección intrahospitalaria, es responsable del 47% de los casos de bacteriemias y del 68% de las infecciones de herida quirúrgica por S. aureus. Numerosos estudios bien desarrollados han demostrado que el contacto de los trabajadores de la salud con los pacientes lleva a la contaminación de sus manos con patógenos. Por ejemplo el personal que cura heridas con SAMR tiene un 80% de posibilidad de portar el germen en sus manos por un tiempo de hasta tres horas. Otro estudio demostró que el 40% de las interacciones entre paciente-enfermero resultaron en la transmisión de Klebsiella a las manos del enfermero, incluso con contactos mínimos como tocarle el hombro al paciente. El germen permaneció en las manos hasta 150 minutos. Datos similares se encontraron para el Clostridium difficile. El lavado de manos removió a los gérmenes. El lavado formal de manos con agua y jabón es requerido cuando hay suciedad. En caso contrario, el HHLG (Hand Hygiene Liaison Group) recomienda el uso del frotado de manos con alcoholglicerol luego del contacto con los pacientes. El frotado de manos con alcohol es más rápido de usar(10-20 contra 90-120 segundos) y puede ser utilizado mientras se camina y habla. Un estudio reciente mostró que causa menos irritación que el jabón. Por otro lado, el alcohol al 70% u otros antisépticos para frotar a base de alcohol decontaminan las manos con más efectividad que el agua y jabón contra una amplia variedad de gérmenes, incluido el S. aureus, Pseudomona aeruginosa, Klebsiella spp. y rotavirus. Existe amplia evidencia en la bibliografía acerca de la reducción en la tasa de infección con el lavado de manos. El efecto es tan grande (odds ratio y riesgo relativo comúnmente publicados de 0,4) que si el lavado de manos fuese una nueva medicación sería aceptada sin objeción. Modelos matemáticos sugieren que pequeños incrementos en la tasa de higiene de manos puedenser altamente efectivos en controlar, por ejemplo, la endemicidad del SAMR. El riesgo de transferencia a las manos del cuidador es proporcional al número de veces que el paciente es tocado. Este grupo y otros proponen ensayos de intervenciones educativas y en el comportamiento. En este sentido, el feedback parece ser más efectivo que las intervenciones educativas, y la influencia de los médicos mayores probablemente sea crítica. Un estudio reciente mejoró la aceptación en un 20% usando feedback y promoviendo el frotado de manos con alcohol.




Como resumen, todos los trabajadores de la salud tienen que ser concientes de la evidencia actual y conocer las recomendaciones vigentes sobre la higiene de manos. Se debe asegurar que hay alcohol para frotar al lado de cada cama. La tasa de infecciones intrahospitalarias debe ser uno de los indicadores de funcionamiento más importantes y de que la higiene de manos se vuelva una parte que habla de la calidad de atención de pacientes diaria de la cultura clínica. Los cambios permanentes en el comportamiento requieren que todo el equipo, principalmente los médicos de más experiencia, tomen la responsabilidad Traducción: Dr. Mariano Fernández J Paediatr Child Health. 1994 Feb;30(1):59-64.

Elimination of methicillin-resistant Staphylococcus aureus from a neonatal intensive care unit after hand washing with triclosan. Webster J, Faoagali JL, Cartwright D. Royal Women's Hospital, Herston, Queensland, Australia. Evaluating hand wash products in terms of user acceptability and effectiveness against methicillin-resistant Staphylococcus aureus (MRSA) has been part of a long-term strategy to eliminate endemic MRSA from the neonatal intensive care unit at the Royal Women's Hospital (Brisbane). Following the introduction of a new hand wash disinfectant (triclosan 1% wt/vol), new cases of MRSA colonization were monitored for 12 months. In addition, the use of antibiotics, the incidence of multi-resistant Gram-negative cultures and neonatal infections were noted. No changes were made to any procedures or protocols during the trial. All babies colonized with MRSA had been discharged from the nursery within 7 months of the introduction of triclosan and in the subsequent 9 months no new MRSA isolates had been reported. Reduction in the use of vancomycin has resulted in a cost saving of approximately $A17,000. The total number of Gram-negative isolates has not increased, although Pseudomonas aeruginosa is now reported more often. Compared with the previous 12 months, fewer antibiotics were prescribed and fewer nosocomial infections recorded (P < 0.05). Am J Infect Control. 1995 Jun;23(3):200-8.

Use of 0.3% triclosan (Bacti-Stat) to eradicate an outbreak of methicillin-resistant Staphylococcus aureus in a neonatal nursery. Zafar AB, Butler RC, Reese DJ, Gaydos LA, Mennonna PA.




Department of Infection Control, Arlington Hospital, VA 22205, USA.

BACKGROUND: Once established in an institution, methicillin-resistant Staphylococcus aureus (MRSA) outbreaks have proved difficult to eradicate, despite intensive infection control measures. This report describes the nosocomial infection with MRSA of 22 male infants in a neonatal nursery during a 7-month period and the infection control procedures that effectively brought this outbreak under control and eliminated recurrence for more than 3 1/2 years. METHODS: After a single index case of bullous impetigo caused by MRSA in a neonate discharged from the nursery 2 weeks previously, an additional 18 cases of MRSA skin infections were clustered in a 7-week period. Aggressive infection control measures were instituted, including changes in umbilical cord care, circumcision procedures, diapers, handwashing, gloves, gowns, linens, disinfection, placement in cohorts of neonates and staff, surveillance, and monitoring. RESULTS: These measures were not effective in slowing the outbreak. The single additional measure of changing handwashing and bathing soap to a preparation containing 0.3% triclosan (Bacti-Stat) was associated with the immediate termination of the acute phase of the MRSA outbreak. CONCLUSION: The nursery has remained free of MRSA for more than 3 1/2 years, attesting to the success of our program.

Am J Infect Control. 1996 Jun;24(3):209-18.

Triclosan: applications and safety. Bhargava HN, Leonard PA. Division of Pharmaceutical Sciences, Massachusetts College of Pharmacy and Allied Health Sciences, Boston 02115, USA.

Triclosan (2,4,4'-trichloro-2'-hydroxydiphenyl ether) is a nonionic, broad spectrum, antimicrobial agent that, because of its favorable safety profile, has been incorporated into a variety of many personal care products, including deodorant soaps, underarm deodorants, shower gels, and health care personnel handwashes. Triclosan exhibits a moderate degree of substantivity to the skin, and, in many products, it imparts a remnant antimicrobial effect. Although direct contact with the material under exaggerated exposure conditions causes dermal irritation in laboratory animals, it has only rarely been associated with skin irritation or sensitization in human being in formulated products. Acute, subacute/subchronic, and chronic toxicity profiles have been established to determine that triclosan is neither an acute oral toxicant nor that it acts as a carcinogen, mutagen, or teratogen. A new application for triclosan is in oral dentifrices for plaque control. Currently under investigation in the United States, it is approved for oral care application in Canada and many European countries.




J Hosp Infect. 1992 Jun;21(2):137-41.

Handwashing in a neonatal intensive care nursery: product acceptability and effectiveness of chlorhexidine gluconate 4% and triclosan 1%. Webster J. Research/Infection Control Supervisor, Royal Women's Hospital, Herston, Queensland, Australia.

The effectiveness of triclosan 1% w/v against methicillin-resistant Staphylococcus aureus (MRSA) and its effect on skin were compared with chlorhexidine gluconate 4% w/v ('Hibiclens') in a 7-week trial. Clinical information of MRSA rates obtained during the previous 10 months and results from earlier user acceptability trials were included. The average number of new cases of MRSA per week was reduced from 3.4 to 0.14 (P less than 0.0001) in the experimental ward whilst no significant changes occurred in the control ward. Staff reported less skin damage and a higher rate of acceptance with the experimental product. Based on results of the trial, a proposal to introduce triclosan for a 12-month study period has been accepted.

Surgical Infections

Literature-Based Evaluation of the Potential Risks Associated with Impregnation of Medical Devices and Implants with Triclosan Peter Gilbert, Andrew J. McBain. Surgical Infections. 2002, 3(supplement 1): 55-63. doi:10.1089/10962960260496343. Peter Gilbert School of Pharmacy and Pharmaceutical Sciences, University of Manchester, Manchester, United Kingdom. Andrew J. McBain School of Pharmacy and Pharmaceutical Sciences, University of Manchester, Manchester, United Kingdom.

Background: This report is a review of the published literature for studies of triclosan that address mechanism of action, efficacy on skin and in the oral cavity, and the potential for development of resistance.




Methods: Triclosan citations from the past three decades were searched using Medline and other search engines. The techniques used in these studies included in vitro antimicrobial sensitivity, molecular genetics, and enzyme and membrane biochemistry. Oral cavity efficacy and resistance studies were conducted in human volunteers in trials lasting up to 7 months. Efficacy on skin was reported in clinical trials lasting up to 12 months.

Results: The minimal inhibitory concentration of triclosan against Staphylococcus aureus and Escherichia coli is reported to be 0.1 and 5.0 μg/mL, respectively. Triclosan acts by blocking enoyl acyl carrier protein reductase, an enzyme essential for fatty acid biosynthesis. Its biocidal activity involves a plethora of nonspecific perturbations of cellular structural elements, including the cell membrane. In the oral cavity, triclosan use was associated with significant reductions in recoverable flora; there was no evidence of resistance or emergence of opportunistic pathogens. On skin, in a neonatal intensive care unit, triclosan use was associated with a significant reduction in methicillin-resistant S. aureus (MRSA) infections, a diminished need for antibiotics, and a decreased incidence of nosocomial infections.

Conclusion: There is currently no evidence that long-term application of triclosan products to the skin or oral cavity selects for triclosan-resistant populations. Given the short-term nature of suture use, it is highly unlikely that such use would do other than reduce the risks of postoperative infection. CDC - Special Issue http://www.cdc.gov/ncidod/eid/vol7no2/larson.htm

Hygiene of the Skin: When Is Clean Too Clean? Elaine Larson Columbia University School of Nursing, New York, New York, USA

Skin hygiene, particularly of the hands, is a primary mechanism for reducing contact and fecal-oral transmission of infectious agents. Widespread use of antimicrobial products has prompted concern about emergence of resistance to antiseptics and damage to the skin barrier associated with frequent washing. This article reviews evidence for the relationship between skin hygiene and infection, the effects of washing on skin integrity, and recommendations for skin care practices. For over a century, skin hygiene, particularly of the hands, has been accepted as a primary mechanism to control the spread of infectious agents. Although the causal link between contaminated hands and infectious disease transmission is one of the best-documented phenomena in clinical science, several factors have recently prompted a reassessment of skin hygiene and its effective practice.

In industrialized countries, exposure to potential infectious risks has increased because of changing sociologic patterns (e.g., more frequent consumption of commercially prepared food and expanded child-care services). Environmental sanitation and public




health services, despite room for improvement, are generally good. In addition, choices of hygienic skin care products have never been more numerous, and the public has increasing access to health- and product-related information (1). This paper reviews evidence for the relationship between skin hygiene and infection, the effects of washing on skin integrity, and recommendations for skin care practices for the public and health-care professionals.

Does Skin Cleansing Reduce Risk for Infection?

Personal Bathing and Washing

There is a clear temporal relationship between improvement in general levels of cleanliness in society and improved health. Greene (2) used historical and cross-cultural evidence and causal inference to associate personal hygiene with better health. However, the role of personal cleanliness in the control of infectious diseases over the past century is difficult to measure, since other factors have changed at the same time (e.g., improved public services, waste disposal, water supply, commercial food handling, and nutrition) (3).

Studies of personal and domestic hygiene and its relationship to diarrhea in developing countries demonstrate the effectiveness of proper waste disposal, general sanitary conditions, and handwashing (4,5). However, aside from hand cleansing, specific evidence is lacking to link bathing or general skin cleansing with preventing infections. Part of the difficulty in demonstrating a causal association between general bathing or skin care and gastrointestinal infection is that interventions to reduce diarrheal disease have been multifaceted, often including health education, improved waste disposal, decontaminating the water supply, and general improvement in household sanitation as well as personal hygiene (6,7). Risk for diarrheal disease has also been linked to the level of parental education (8). Multiple influences complicate definition of the impact of any single intervention.

In 11 studies reviewed by Keswick et al. (9), use of antimicrobial soaps was associated with substantial reductions in rates of superficial cutaneous infections. Another 15 experimental studies demonstrated a reduction in bacteria on the skin with use of antimicrobial soaps, but none assessed rates of infection as an outcome.

Extensive studies of showering and bathing conducted since the 1960s demonstrated that these activities increase dispersal of skin bacteria into the air and ambient environment (10-12), probably through breaking up and spreading of microcolonies on the skin surface and resultant contamination of surrounding squamous cells. These studies prompted a change in practice among surgical personnel, who are now generally discouraged from showering immediately before entering the operating room. Other investigators have shown that the skin microflora varies between persons but is

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remarkably consistent for each person over time. Even without bathing for many days, the flora remain qualitatively and quantitatively stable (13-15).

For surgical or other high-risk patients, showering with antiseptic agents has been tested for its effect on postoperative wound infection rates. Such agents, unlike plain soaps, reduce microbial counts on the skin (16-18). In some studies, antiseptic preoperative showers or baths have been associated with reduced postoperative infection rates, but in others, no differences were observed (19-21). Whole-body washing with chlorhexidine-containing detergent has been shown to reduce infections among neonates (22), but concerns about absorption and safety preclude this as a routine practice. Several studies have demonstrated substantial reductions in rates of acquisition of methicillin-resistant Staphylococcus aureus in surgical patients bathed with a triclosan-containing product (23,24). Hence, preoperative showering or bathing with an antiseptic may be justifiable in selected patient populations.

Hand Hygiene for the General Public

Much contemporary evidence for a causal link between handwashing and risk for infection in community settings comes from industrialized countries (5,7,25-27). Although many of these studies may be limited by confounding by other variables, evidence of an important role for handwashing in preventing infections is among the strongest available for any factor studied. Reviews of studies linking handwashing and reduced risk for infection have been recently published (28,29). The most convincing evidence of the benefits of handwashing for the general public is for prevention of infectious agents found transiently on hands or spread by the fecal-oral route or from the respiratory tract (30). Plain soaps are considered adequate for this purpose.

Several highly publicized, serious outbreaks from commercially prepared foods have raised questions about food safety and the hygienic practices of food handlers and others in the service professions. Despite public awareness, however, handwashing generally does not meet recommended standards--members of the public wash too infrequently and for short periods of time (31).

These factors have led to suggestions that antimicrobial products should be more universally used, and a myriad of antimicrobial soaps and skin care products have become commercially available. While antimicrobial drug-containing products are superior to plain soaps for reducing both transient pathogens and colonizing flora, widespread use of these agents has raised concerns about the emergence of bacterial strains resistant to antiseptic ingredients such as triclosan (32,33). Such resistance has been noted in England and Japan (34), and molecular mechanisms for the development of resistance have been proposed (32,35). Although in some settings exposure to antiseptics has occurred for years without the appearance of resistance, a recent study described mutants of Escherichia coli selected for resistance to one disinfectant that were also multiply-antibiotic resistant (35). Some evidence indicates that long-term use



















of topical antimicrobial agents may alter skin flora (36,37). The question remains whether antimicrobial soaps provide sufficient benefit in reducing transmission of infection without added risk or cost.

Hand Hygiene in Health-Care Settings

Issues regarding hand hygiene practices among health-care professionals have been widely discussed and may be even more complicated than those in the general public. Unless patient care involves invasive procedures or extensive contact with blood and body fluids, current guidelines recommend plain soap for handwashing (38,39); however, infection rates in adult or neonatal intensive care units or surgery may be further reduced when antiseptic products are used (40-42).

Skin Barrier Properties and Effect of Hand Hygiene Practices

The average adult has a skin area of about 1.75 m2. The superficial part of the skin, the epidermis, has five layers. The stratum corneum, the outermost layer, is composed of flattened dead cells (corneocytes or squames) attached to each other to form a tough, horny layer of keratin mixed with several lipids, which help maintain the hydration, pliability, and barrier effectiveness of the skin. This horny layer has been compared to a wall of bricks (corneocytes) and mortar (lipids) and serves as the primary protective barrier (43). Approximately 15 layers make up the stratum corneum, which is completely replaced every 2 weeks; a new layer is formed approximately daily (44). From healthy skin, approximately 107 particles are disseminated into the air each day, and 10% of these skin squames contain viable bacteria (45). The dispersal of organisms is greater in males than in females and varies between persons using the same hygienic regimen by as much as fivefold (46).

Water content, humidity, pH, intracellular lipids, and rates of shedding help retain the protective barrier properties of the skin. When the barrier is compromised (e.g., by hand hygiene practices such as scrubbing), skin dryness, irritation, cracking, and other problems may result. Although the palmar surface of the hand has twice as many cell layers and the cells are >30 times thicker than on the rest of the skin (47), palms are quite permeable to water (48).

Long-term changes in skin pH associated with handwashing may pose a concern since some of the antibacterial characteristics of skin are associated with its normally acidic pH (49). In one report, pH increased 0.6 to 1.8 units after handwashing with plain soap for 1 to 2 min and then gradually declined to baseline levels over a period of 45 min to 2 hr (50). Some soaps can be associated with long-standing changes in skin pH, reduction in fatty acids, and subsequent changes in resident flora such as propionibacter (51).

In an investigation of the effect on skin of repeated use of two washing agents, all skin function tests (stratum corneum capacitative resistance, lipids, transepidermal water
















loss, pH, laser Doppler flow, and skin reddening) were markedly changed after a single wash, and after 1 week further damage was noted (52). In a study of irritant skin reactions induced by three surfactants, damage lasted for several days; complete skin repair was not achieved for 17 days (53).

Soaps and detergents have been described as the most damaging of all substances routinely applied to skin (43). Anionic and cationic detergents are more harmful than nonionic detergents (54), and increased concentrations of surfactant result in more rapid, severe damage (55). Each time the skin is washed, it undergoes profound changes, most of them transient. However, among persons in occupations such as health care in which frequent handwashing is required, long-term changes in the skin can result in chronic damage, irritant contact dermatitis and eczema, and concomitant changes in flora.

Irritant contact dermatitis, which is associated with frequent handwashing, is an occupational risks for health-care professionals, with a prevalence of 10% to 45% (56-58). The prevalence of damaged skin on the hands of 410 nurses was reported to be 25.9% in one survey, with 85.6% of nurses reported to have problems at some time. Skin damage was correlated with frequency of glove use and handwashing (56). Washing with plain soap may actually increase the potential for microbial transmission because of a 17-fold increase in the dispersal of bacterial colonies from the skin of the hands (59). Skin condition clearly plays a major role in risk for transmission.

Microbiology of Hands of Health-Care Professionals

Damaged skin more often harbors increased numbers of pathogens. Moreover, washing damaged skin is less effective at reducing numbers of bacteria than washing normal skin, and numbers of organisms shed from damaged skin are often higher than from healthy skin (60,61). The microbial flora on the clean hands of nurses (samples taken immediately after handwashing) have been reported in several recent studies (Table). Methicillin resistance among coagulase-negative staphylococcal flora on hands did not seem to increase during the 1980s to the 1990s, and tetracycline resistance decreased (Table).

Table. Microbial flora colonizing hands of health-care professionals

A. Microbial counts

Year (reference) Sample (# subjects) Mean log10 CFUa











http://www.cdc.gov/ncidod/eid/vol7no2/larson.htm#Table.

http://www.cdc.gov/ncidod/eid/vol7no2/larson.htm#Table.




1986 (62) Staff of bone marrow transplant unit (n = 22)

4. 89

1992 (63) Pediatric staff, Peru (n = 62)

5.88

1997 (64) Nurses in acute care unit (n = 40)

5.61

B. Resistance of coagulase-negative staphylococcal flora

Resistant (%) to Year (reference) Sample (no. of

isolates) methicillin tetracycline

1986 (62) Staff of bone marrow transplant unit (50)

68.0 23.0

1988 (65) oncology, dermatology staff (152)

50.7 30.7

1992 (63) Pediatric staff, Peru (279)

40.9 45.4

1997 (64) Acute care nurses (122)

59.0 10.5

aCFU = Colony-forming unit

Even with use of antiseptic preparations, which substantially reduce counts of hand flora, no reductions beyond an equilibrium level are attained (

When Is Clean Too Clean?

66). The numbers of organisms spread from the hands of nurses who washed frequently with an antimicrobial soap actually increased after a period of time; this increase is associated with declining skin health (67). In a recent survey, nurses with damaged hands were twice as likely to be colonized with S. hominis, S. aureus, gram-negative bacteria, enterococci, and Candida spp. and had a greater number of species colonizing the hands (64).

The trend in both the general public and among health-care professionals toward more frequent washing with detergents, soaps, and antimicrobial ingredients needs careful reassessment







in light of the damage done to skin and resultant increased risk for harboring and transmitting infectious agents. More washing and scrubbing are unlikely to be better and may, in fact, be worse. The goal should be to identify skin hygiene practices that provide adequate protection from transmission of infecting agents while minimizing the risk for changing the ecology and health of the skin and increasing resistance in the skin flora.

Recommendations for the General Public

Bathing or showering cleans the skin by mechanical removal of bacteria shed on corneocytes. Bacterial counts are at least as high or higher after bathing or showering with a regular soap than before. Frequent bathing has aesthetic and stress-relieving benefits but serves little microbiologic purpose. Mild, nonantimicrobial soap should suffice for routine bathing. Bathing with an antimicrobial product reduces rates of cutaneous infection and could be beneficial when skin infections are likely or before certain surgical procedures. With those exceptions, available data do not support a recommendation for bathing with antimicrobial products.

No single recommendation for hand hygiene practices in the general population would be adequate. The potential advantage of sustained antimicrobial activity for certain occupations (e.g., food handlers and child-care providers) must be balanced with the theoretical possibility of emergence of resistant strains and perhaps other, as yet unrecognized, safety issues.

An alternative to detergent-based antiseptic products is the use of alcohol hand rinses, which have recently become widely available over the counter. Their advantages include rapid and broad-spectrum activity, excellent microbicidal characteristics, and lack of potential for emergence of resistance. Alcohol-based products could be recommended for use among persons who need immediate protection after touching contaminated surfaces or before and after contact with someone at high risk for infection.

Since hands are a primary mode of fecal-oral and respiratory transmission, specific indications for use of antiseptic hand products by the general public are close physical contact with persons at high risk for infection (e.g., neonates, the very old, or immunosuppressed); close physical contact with infected




persons; infection with an organism likely to be transmitted by direct contact (diarrhea, upper respiratory infection, skin infections); or work in a setting in which infectious disease transmission is likely (food preparation, crowded living quarters such as chronic-care residences, prisons, child-care centers, and preschools).

Recommendations for the Health-Care Professional

Detergent-Based Antiseptics or Alcohol

Because of increasingly vulnerable patient populations, the demand for hand hygiene among health-care professionals has never been greater. However, frequent handwashing is not only potentially damaging to skin, it is also time-consuming and expensive (68). Finnish investigators demonstrated that after frequent washing the hands of patient-care providers became damaged and posed greater risk to themselves and patients than if they had washed less often. A mild emulsion cleansing rather than handwashing with liquid soap was associated with a substantial improvement in the skin of nurses' hands (69). Alcohol-based formulations are superior to antiseptic detergents for rapid microbial killing on skin (66,67,70-72) and, with the addition of appropriate moisturizers, are probably milder (67,73,74). Since alcohols are rapid acting, are broad spectrum, and require no washing or drying, damage caused by detergents and mechanical friction from toweling is avoided.

Use of Lotions and Moisturizers

Moisturizing is beneficial for skin health and reducing microbial dispersion from skin, regardless of whether the product used contains an antibacterial ingredient (75-77). Because of differences in the content and formulations of lotions and creams, products vary greatly in their effectiveness (78,79). Lotions used with products containing chlorhexidine gluconate must be carefully selected to avoid neutralization by anionic surfactants (80). The role of emollients and moisturizers in improving skin health and reducing microbial spread is an area for additional research.

To improve the skin condition of health-care professionals and reduce their chances of harboring and shedding microorganisms











from the skin, the following measures are recommended: 1) For damaged skin, mild, nonantimicrobial skin cleansing products may be used to remove dirt and debris. If antimicrobial action is needed (e.g., before invasive procedures or handling of highly susceptible patients) a waterless, alcohol-based product may be used. 2) In clinical areas such as the operating room and neonatal and transplant units, shorter, less traumatic washing regimens may be used instead of lengthy scrub protocols with brushes or other harsh mechanical action. 3) Effective skin emollients or barrier creams may be used in skin-care regimens and procedures for staff (and possibly patients as well). 4) Skin moisturizing products should be carefully assessed for compatibility with any topical antimicrobial products being used and for physiologic effects on the skin (81).

Conclusions

From the public health perspective, more frequent use of current hygiene practices may not necessarily be better (i.e., perhaps sometimes clean is "too clean"), and the same recommendations cannot be applied to all users or situations. Future investigation is likely to improve understanding of the interaction between skin physiology, microbiology, and ecology and the role of the skin in the transmission of infectious diseases.

Dr. Larson is professor of pharmaceutical and therapeutic research, The School of Nursing, and professor of epidemiology, Mailman School of Public Health, Columbia University. She is editor of the American Journal of Infection Control and former chair of the Healthcare Infection Control Practices Advisory Committee (HICPAC) and member of CDC's National Center for Infectious Diseases Board of Scientific Counselors.

Address for correspondence: Elaine Larson, Columbia University School of Nursing, 630 W. 168th St., New York, NY 10032, USA; fax: 212-305-0722; e-mail: [email protected]

References

1. Sattar SA, Tetro J, Springthorpe VS. Impact of changing societal trends on the spread of infections in American and Canadian homes. Am J Infect Control 1999;27:S4-S21.


mailto:[email protected]

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=10586141&dopt=Abstract






2. Green VW. Cleanliness and the health revolution. New York: Soap and Detergent Association; 1984. Available from: URL: http://www.sdahq.org/about/order_formjs.html

3. Larson E. Social and economic impact of infectious diseases--United States. Clin Performance and the Quality of Health Care 1997;5:31-7.

4. Ekanem EE, Akitoye CO, Adedeji OT. Food hygiene behaviour and childhood diarrhoea in Lagos, Nigeria: a case-control study. J Diarrhoeal Dis Res 1991;9:219-26.

5. Alam N, Wojtyniak B, Henry FJ, Rahaman MM. Mothers' personal and domestic hygiene and diarrhoea incidence in young children in rural Bangladesh. Int J Epidemiol 1989;18:242-7.

6. Feachem RG. Interventions for the control of diarrhoeal diseases among young children: promotion of personal and domestic hygiene. Bull World Health Organ 1984;62:467-76.

7. Haggerty PA, Muladi K, Kirkwood BR, Ashworth A, Manunebo M. Community-based hygiene education to reduce diarrhoeal disease in rural Zaire: impact of the intervention on diarrhoeal morbidity. Int J Epidemiol 1994;23:1050-9.

8. Manun'ebo MN, Haggerty PA, Kalengaie M, Ashworth A, Kirkwood BR. Influence of demographic, socioeconomic and environmental variables on childhood diarrhoea in a rural area of Zaire. J Trop Med Hyg 1994;97:31-8.

9. Keswick BH, Berge CA, Bartolo RG, Watson DD. Antimicrobial soaps: their role in personal hygiene. In: Aly R, Beutner KR, Maibach H, editors. Cutaneous infection and therapy. New York: Marcel Dekker, Inc.; 1997. p. 49-82.

10. Speers R, Bernard H, O'Grady F, Shooter RA. Increased dispersal of skin bacteria into the air after shower-baths. Lancet 1965;1:478-83.

11. Hall GS, Mackintosh CA, Hoffman PN. The dispersal of bacteria and skin scales from the body after showering

http://www.cdc.gov/ncidod/eid/vol7no2/disclaimer_page4.htm
















and after application of a skin lotion. J Hyg (Camb) 1986;97:289-98.

12. Ulrich JA. Dynamics of bacterial skin populations. In: Maibach HI, Hildick-Smith G, editors. Skin bacteria and their role in infection. New York: McGraw-Hill; 1965. p. 219-34.

13. Evans CA. Persistent individual differences in the bacterial flora of the skin of the forehead: numbers of propionibacteria. J Invest Dermatol 1975;64:42-6.

14. Leyden JJ, McGinley KJ, Nordstrom KM, Webster GF. Skin microflora. J Invest Dermatol 1987;88:65s-72.

15. Hartmann AA. Daily bath and its effect on the normal human skin flora quantitative: and qualitative investigations of the aerobic skin flora. Arch Dermatol Res 1979;265:153-64.

16. Paulson DS. Efficacy evaluation of a 4% chlorhexidine gluconate as a full-body shower wash. Am J Infect Control 1993;21:205-9.

17. Kaiser AB, Kernodle DS, Barg NL, Petracek MR. Influence of preoperative showers on staphylococcal skin colonization: a comparative trial of antiseptic skin cleansers. Ann Thorac Surg 1988;45:35-8.

18. Byrne DJ, Napier A, Cuschieri A. Rationalizing whole body disinfection. J Hosp Infect 1990;15:183-7.

19. Mackenzie I. Preoperative skin preparation and surgical outcome. J Hosp Infect 1988;11(Suppl B):27-32.

20. Rotter ML, Larsen SO, Cooke EM, Dankert J, Daschner F, Greco D, et al. A comparison of the effects of preoperative whole-body bathing with detergent alone and with detergent containing chlorhexidine glucontate on the frequency of wound infections after clean surgery. J Hosp Infect 1988;11:310-20.

21. Ayliffe GAJ, Noy MF, Babb JR, Davies JG, Jackson J. A comparison of pre-operative bathing with chlorhexidine-detergent and non-medicated soap in the prevention of




























wound infection. J Hosp Infect 1983;4:237-44.

22. Meberg A, Schoyen R. Bacterial colonization and neonatal infections. Effects of skin and umbilical disinfection in the nursery. Acta Paediatr Scand 1985;74:366-71.

23. Tuffnell DJ, Croton RS, Hemingway DM, Hartley MN, Wake PN, Garvey RJ. Methicillin resistant Staphylococcus aureus; the role of antisepsis in the control of an outbreak. J Hosp Infect 1987;10:255-9.

24. Bartzokas CA, Paton JH, Gibson MF, Graham F, McLoughlin GA, Croton RS. Control and eradication of methicillin-resistant Staphylococcus aureus on a surgical unit. N Engl J Med 1984;311:1422-5.

25. Sempertegui F, Estrella B, Correa E, Aguirre L, Saa B, Torres M, et al. Risk of diarrheal disease in Ecuadorian day-care centers. Pediatr Infect Dis 1995;14:606-12.

26. Shahid NS, Greenough WB, Samadi AR, Huq MI, Rahman N. Hand washing with soap reduces diarrhoea and spread of bacterial pathogens in a Bangladesh village. J Diarrhoeal Dis Res 1996;14:85-9.

27. Rudland S, Little M, Kemp P, Miller A, Hodge J. The enemy within: diarrheal rates among British and Australian troops in Iraq. Mil Med 1996;161:728-31.

28. Larson E. A causal link between hand washing and risk of infection? Examination of the evidence. Infect Control Hosp Epidemiol 1988;9:28-36.

29. Bryan JL, Cohran J, Larson EL. Hand washing: a ritual revisited. Crit Care Nurs Clin North Am 1995;7:617-26.

30. Gwaltney JM, Moskalski PB, Hendley JO. Hand-to-hand transmission of rhinovirus colds. Ann Intern Med 1978;88:463-7.

31. ASM inagurates nationwide public education effort. ASM News 1996;62:547-8.

32. Russell AD, Hammond SA, Morgan JR. Bacterial resistance to antiseptics and disinfectants. J Hosp Infect
























33. APIC position statement. The use of antimicrobial household products. APIC News 1997;(Nov/Dec):13.

34. Sasatsu M, Shimizu K, Noguchi N, Kong M. Triclosan-resistant Staphylococcus aureus [letter]. Lancet 1993;342:248.

35. Moken MC, McMurry LM, Levy SB. Selection of multiple-antibiotic-resistant (mar) mutants of Escherichia coli by using the disinfectant pine oil: roles of the mar and acrAB loci. Antimicrob Agents Chemother 1997;41:2770-2.

36. Ehrenkranz NJ, Taplin D, Butt P. Antibiotic-resistant bacteria on the nose and skin: colonization and cross-infection. Proceedings from Sixth Interscience Conference on Antimicrobial Agents and Chemotherapy. Philadelphia: American Society for Microbiology. Antimicrob Agents Chemother; 1966. p. 255-64.

37. Bruun JN, Solberg CO. Hand carriage of gram negative bacilli and Staphylococcus aureus. BMJ 1973;2:580-2.

38. Hospital Infection Control Practices Advisory Committee. Guideline for isolation precautions in hospitals. Am J Infect Control 1996;24:24-52.

39. Larson E, the 1992, 1993, and 1994 APIC Guideline Committees. APIC guideline for handwashing and hand antisepsis in health care settings. Am J Infect Control 1995;23:251-69.

40. Doebbeling BN, Stanley GL, Sheetz CT, Pfaller MA, Houston AK, Annis L, et al. Comparative efficacy of alternative handwashing agents in reducing nosocomial infections in intensive care units. N Engl J Med 1992;327:88-93.

41. Zafar AB, Butler RC, Reese DJ, Gaydos LA, Mennonna PA. Use of 0.3% triclosan (Bacti-Stat*) to eradicate an outbreak of methicillin-resistant Staphylococcus aureus in a neonatal nursery. Am J Infect Control 1995;23:200-8.

42. Webster J, Faoagali JL, Cartwright D. Elimination of methicillin-resistant Staphylococcus aureus from a





















neonatal intensive care unit after hand washing with triclosan. J Paediatr Child Health 1994;30:59-64.

43. Jarrett A, editor. The physiology and pathophysiology of the skin. New York: Academic Press; 1978.

44. Schaefer H, Redelmeier TE. Skin barrier: principles of percutaneous absorption. Basel: Karger; 1996.

45. Noble WC, Davies RR. Studies on the dispersal of staphylococci. J Clin Pathol 1965;18:16-20.

46. Noble WC. Dispersal of skin microorganisms. Br J Dermatol 1975;93:477-85.

47. Holbrook KA, Odland GF. Regional differences in the thickness (cell layers) of the human stratum: an ultra-structural analysis. J Invest Dermatol 1974;62:415.

48. Blank IH. Factors which influence the water content of the stratum corneum. J Invest Dermatol 1952;18:433.

49. Maki DG. The use of antiseptics for handwashing by medical personnel. J Chemother 1989;1(Suppl):3-11.

50. Klauder JV, Gross BA. Actual causes of certain occupational dermatoses. III. a further study with special reference to effect of alkali on the skin, effect of soap on pH of skin, modern cutaneous detergents. Arch Dermatol Symp 1951;63:1-23.

51. Hoffler U, Gloor M, Peters G, Ko HL, Brautigam A, Thurn A, et al. Qualitative and quantitative investigations on the resident bacterial skin flora in healthy persons and in the non-affected skin of patients with seborrheic eczema. Arch Dermatol Res 1980;268:297-312.

52. Grunewald AM, Gloor M, Gehring W, Kleesz P. Damage to the skin by repetitive washing. Contact Dermatitis 1995;32:225-32.

53. Wilhelm KP, Freitag G, Wolff HH. Surfactant-induced skin irritation and skin repair. Evaluation of the acute human irritation model by noninvasive techniques. J Am Acad Dermatol 1994;30:944-9.
















54. Dugard PH, Scheuplein RJ. Effect of ionic surfactants on the permeability of human epidermis: an electrometric study. J Invest Dermatol 1973;60:263-5.

55. Scheuplein RJ, Ross L. Effects of surfactants and solvents on the permeability of epidermis. J Soc Cosmetol Chem 1970;21:853-6.

56. Larson E, Friedman C, Cohran J, Treston-Aurand J, Green S. Prevalence and correlates of skin damage on hands of nurses. Heart Lung 1997;26:404-12.

57. Sproat LJ, Uveges RE. Epidemiology of hand dermatitis in dental personnel. Mil Med 1995;160:335-8.

58. Stingeni L, Lapomarda V, Lisi P. Occupational hand dermatitis in hospital environments. Contact Dermatitis 1995;33:172-6.

59. Meers PD, Yeo GA. Shedding of bacteria and skin squames after handwashing. J Hyg (Camb) 1978;81:99-105.

60. Ojajarvi J. Effectiveness of hand washing and disinfection methods in removing transient bacteria after patient nursing. J Hyg (Camb) 1980;85:193-203.

61. Parry MF, Hutchinson JH, Brown NA, Wu CH, Estreller L. Gram-negative sepsis in neonates: a nursery outbreak due to hand carriage of Citrobacter diversus. Pediatrics 1980;65:1105-9.

62. Larson E, McGinley K, Grove G, Leyden J, Talbot G. Physiologic, microbiologic, and seasonal effects of handwashing on the skin of health care personnel. Am J Infect Control l986;l4:5l-9.

63. Larson E, McGinley K, Foglia A, Leyden J, Boland N, Larson J, et al. Handwashing practices and resistance and density of bacterial hand flora on two pediatric units in Lima, Peru. Am J Infect Control 1992;20:65-72.

64. Larson EL, Norton Hughes CA, Pyrek JD, Sparks SM, Cagatay EU, Bartkus JM. Changes in bacterial flora associated with skin damage on hands of health care




















personnel. Am J Infect Control 1998;26:513-21.

65. Horn W, Larson E, McGinley K, Leyden JJ. Microbial flora on the hands of health care personnel: differences in composition and antibacterial resistance. Infect Control Hosp Epidemiol 1988;9:189-93.

66. Lilly HA, Lowbury EJL, Wilkins MD. Limits to progressive reduction of resident skin bacteria by disinfection. J Clin Pathol 1979;32:382-5.

67. Ojajarvi J, Makela P, Rantsalo I. Failure of hand disinfection with frequent hand washing: a need for prolonged field studies. J Hyg (Camb) 1977;79:107-19.

68. Voss A, Widmer AF. No time for handwashing? Handwashing versus alcoholic rub: can we afford 100% compliance? Infect Control Hosp Epidemiol 1997;28:205-8.

69. Lauharanta J, Ojajarvi J, Sarna S, Makela P. Prevention of dryness and eczema of the hands of hospital staff by emulsion cleansing instead of washing with soap. J Hosp Infect 1991;17:207-15.

70. Morrison AJ, Gratz J, Cabzudo I, Wenzel RP. The efficacy of several new handwashing agents for removing non-transient bacterial flora from hands. Infect Control 1986;7:268-72.

71. Rotter ML, Koller W. Test models for hygienic handrub and hygienic handwash: the effects of two different contamination and sampling techniques. J Hosp Infect 1992;20;163-71.

72. Hobson DW, Woller W, Anderson L, Guthery E. Development and evaluation of a new alcohol-based surgical hand scrub with persistent antimicrobial characteristics and brushless application. Am J Infect Control 1998;26:507-12.

73. Larson E, Eke P, Laughon B. Efficacy of alcohol-based hand rinses under frequent use conditions. Antimicrob Agents Chemother 1986;30:542-4.

74. Larson E, Silberger M, Jakob K, Whittier S, Lai L,























DellaLatta P, et al. Assessment of alternative hand hygiene regimens to improve skin health among neonatal ICU nurses. Heart Lung 2000;29:136-42.

75. Murray J, Calman RM. Control of cross-infection by means of an antiseptic hand cream. BMJ 1955;1:81-3.

76. Zelickson AS, Zelickson BD, Zelickson BM. Measurements by transmission electron microscopy of "dry" skin before and after application of a moisturizing cream. Am J Dermatopathol 1982;4:205-8.

77. Grunewald AM, Gloor M, Gehring W, Kleesz P. Efficacy of barrier creams. In: Elsner P, Maibach HI, editors. Irritant dermatitis: new clinical and experimental aspects. Curr Probl Dermatol. 1995;23:187-97.

78. Loden M. Barrier recovery and influence of irritant stimuli in skin treated with a moisturinzing cream. Contact Dermatitis 1997;36:256-60.

79. Schluter-Wigger W, Elsner P. Efficacy of four commercially available protective creams in the repetitive irritation test (RIT). Contact Dermatitis 1996;34:278-83.

80. Frantz SW, Haines KA, Azar CG, Ward JI, Homan SM, Roberts RB. Chlorhexidine gluconate activity against clinical isolates of vancomycin-resistant Enterococcus faecium (VREF) and the effects of moisturizing agents on CGH residue accumulation on the skin. J Hosp Infect 1997;37:157-64.

81. Larson E. Skin hygiene and infection prevention: more of the same or different approaches? Clin Infect Dis 1999;29:1287-94.


















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